Progression-free survival by investigator versus blinded independent central review in newly diagnosed patients with high-grade serous ovarian cancer: Analysis of the VELIA/GOG-3005 trial

Autor: Aikou Okamoto, Carol Aghajanian, Karina Dahl Steffensen, Gini F. Fleming, Robert L. Coleman, Michael A. Bookman, Elizabeth M. Swisher, Michael Friedlander, Camille Gunderson Jackson, Christine K. Ratajczak, Danielle Sullivan
Rok vydání: 2021
Předmět:
0301 basic medicine
Oncology
medicine.medical_specialty
Paclitaxel
Veliparib
Concordance
Population
Carcinoma
Ovarian Epithelial
Phase 3
BICR
Carboplatin
03 medical and health sciences
chemistry.chemical_compound
0302 clinical medicine
Ovarian cancer
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
medicine
Humans
Progression-free survival
education
neoplasms
Response Evaluation Criteria in Solid Tumors
Ovarian Neoplasms
education.field_of_study
business.industry
VELIA
BRCA mutation
Hazard ratio
Reproducibility of Results
Obstetrics and Gynecology
medicine.disease
Survival Analysis
Progression-Free Survival
Confidence interval
PARP inhibitor
030104 developmental biology
GOG-3005
chemistry
Research Design
Data Interpretation
Statistical
030220 oncology & carcinogenesis
Benzimidazoles
Female
Neoplasm Grading
business
Zdroj: Aghajanian, C, Bookman, M A, Fleming, G F, Swisher, E M, Steffensen, K D, Friedlander, M, Okamoto, A, Jackson, C G, Sullivan, D, Ratajczak, C K & Coleman, R L 2021, ' Progression-free survival by investigator versus blinded independent central review in newly diagnosed patients with high-grade serous ovarian cancer : Analysis of the VELIA/GOG-3005 trial ', Gynecologic Oncology, vol. 162, no. 2, pp. 375-381 . https://doi.org/10.1016/j.ygyno.2021.05.031
ISSN: 0090-8258
Popis: OBJECTIVE: In the phase 3 VELIA/GOG-3005 trial, veliparib added to carboplatin-paclitaxel and continued as maintenance improved progression-free survival (PFS) compared to carboplatin-paclitaxel alone in patients with newly diagnosed ovarian carcinoma. Primary analysis of PFS was by investigator (INV) assessment, with a supplemental analysis of PFS by blinded independent central review (BICR).METHODS: Patients received veliparib or placebo with carboplatin-paclitaxel (6 cycles) and as maintenance (30 additional cycles). The primary analysis compared PFS in the veliparib-throughout arm to the carboplatin-paclitaxel only arm in the BRCA mutation (BRCAm), homologous recombination deficiency (HRD), and intention-to-treat (ITT) populations. Exploratory analyses of PFS in BRCA wildtype (BRCAwt), homologous recombination proficient (HRP), and HRD + BRCAwt populations were also performed. PFS per BICR and overall concordance rates between INV and BICR assessments were analyzed.RESULTS: Hazard ratios for PFS by INV and BICR were consistent in each of the primary analysis and exploratory populations. In the ITT population, median PFS per INV was 23.5 months in the veliparib-throughout arm versus 17.3 months in the control arm (hazard ratio [HR] 0.683, 95% confidence interval [CI] 0.562-0.831; P CONCLUSIONS: Hazard ratios for PFS per BICR and per INV were consistent, with no suggestion of investigator bias. These findings support the reliability of PFS by INV in ovarian cancer trials.
Databáze: OpenAIRE
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